NCT02826538

Brief Summary

Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 30, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

June 30, 2016

Last Update Submit

July 11, 2019

Conditions

Fracture of HumerusFracture of Ulna RadiusFracture of ClavicleFracture of HandFracture of PelvisFracture of FemurFracture of Tibia FibulaFracture of Skull

Outcome Measures

Primary Outcomes (1)

  • 3D difference between preoperative plan and surgery

    For each surgery the discrepancy of the postoperative result compared to the preoperative planning is calculated by measuring all 6 degrees of freedom (3xrotation, 3xtranslation). The discrepancy between a simulated perfect postoperative result and the actual postoperative result is assessed in degree (rotation) and millimeters (translation). These measures are used to compare the outcome of the two different study Groups.

    12 months

Secondary Outcomes (2)

  • surgical outcome assesed by validated outcome instruments

    12 months

  • range of motion

    12 months

Study Arms (2)

patient specific guides

EXPERIMENTAL

fracture fixation with 3D planning and use of patient-specific instruments

Device: fracture fixation with patient specific guides

standard procedure

ACTIVE COMPARATOR

standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments

Device: standard procedure of fracture fixation

Interventions

fracture fixation with patient specific guidesDEVICE

Using the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation

Also known as: MyOsteotomy
patient specific guides
standard procedure of fracture fixationDEVICE

the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference

standard procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fracture of clavicle, upper extremity, lower extremity or pelvis,tibia, fibula,Femur, with indication for fracture Fixation
  • clinical indication for a computed tomography of the fractured bone
  • \>18 years of Age
  • Patient is able to give informed consent

You may not qualify if:

  • pregnancy or nursing women
  • non-compliance of the patient to follow the clinical study protocol, drug abuse or alcohol abuse
  • allergy to Polyamid PA 2200
  • no available technique for fracture Fixation which could be performed, in case of applying the medical device is not possible.
  • Applying the medical device is not possible, because of technical or anatomical reasons.
  • other clinical significant accompanying symptoms (tumor, infection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universital Hospital Zurich

Zurich, 8001, Switzerland

Location

University Hospital Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Humeral FracturesHip FracturesFemoral FracturesSkull Fractures

Interventions

Fracture Fixation

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, BoneHip InjuriesLeg InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Phillipp Furnstahl, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

  • Philipp Furnstahl, PhD

    Balgrist University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 11, 2016

Study Start

July 30, 2017

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

CH(2)